Submission Details
| 510(k) Number | K873612 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 08, 1987 |
| Decision Date | November 23, 1987 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K873612 is an FDA 510(k) clearance for the IMSI, VITAL CALL, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Intl. Management Services, Inc. (Lincoln, US). The FDA issued a Cleared decision on November 23, 1987, 76 days after receiving the submission on September 8, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.
| 510(k) Number | K873612 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 08, 1987 |
| Decision Date | November 23, 1987 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQA — System, Environmental Control, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3725 |